The next city for 10 billion drugs: NASH drugs

【Pharmaceutical Network Market Analysis】Non-alcoholic fatty liver disease (NAFLD) refers to a disease of excessive lipid deposition in the liver in patients who do not have a history of alcoholism or other secondary causes of hepatic steatosis, and non-alcoholic steatohepatitis (NASH) is the progressive stage of NAFLD, and severe patients will lead to liver fibrosis, cirrhosis or liver cancer
.

In China, it is estimated that by 2025, the number of new cases of NASH in China each year may reach 2 million
.

According to the recent research report released by Southwest Securities, China's NASH drug market is expected to reach tens of billions of yuan by 2030, becoming the next city
following PD-1, ADC, CAR-T and other tens of billions of drugs.

Current drugs used in NASH therapy include nuclear agonists such as FXR agonists, PPAR agonists, chemokine receptor inhibitors, thyroid hormone receptor-β agonists, and GLP-1, FGF 21, or SGLT2 inhibitors
.

However, no drug for this disease has been approved
worldwide.

The U.
S.
FDA BELIEVES THAT IDENTIFYING THERAPIES THAT CAN SLOW, STOP, OR REVERSE THE PROGRESSION OF NASH AND NAFLD WILL ADDRESS UNMET MEDICAL NEEDS
.

In recent years, with the gradual heating of NASH market research and development, capital has increased, and this area has also attracted the attention
of the market.

At present, on the track, in addition to some multinational pharmaceutical companies, there are currently many domestic pharmaceutical companies actively layout
.

On the evening of September 22, China Biopharmaceutical announced that Chia Tai Tianqing, a subsidiary of the company, signed an agreement with the French Inventiva (IVA) company to obtain the exclusive licensing rights of the IVA treatment of non-alcoholic steatohepatitis treatment drug lanifibranor in Greater China, and the drug was certified
by the US FDA as a "breakthrough therapy".

Under the terms of the agreement, Chia Tai Tianqing will pay Inventiva a down payment of $12 million and a potential clinical and registration milestone payment
of up to $40 million.

After the product is approved for marketing in Greater China, Inventiva will receive additional commercialization milestones and tiered commissions
based on net sales in Greater China from Chia Tai Tianqing.

Lanifibranor is a small molecule taken orally that induces anti-fibrotic, anti-inflammatory, and beneficial metabolic changes
in the body by activating three PPAR subtypes.

At present, the FDA has granted lanifibranor breakthrough therapy certification and fast-track qualification for the treatment of NASH, is conducting phase III clinical trials in the United States, and is expected to become the world's first approved oral drug for the treatment of Nash, with potential best-in-class efficacy to meet the needs of China's NASH treatment market
.

In addition to Chia Tai Tianqing, there are also Tasly
B1344 injection and CSPC TG103 injection on the NASH new drug track.

Tasly Research and Development B1344 Injection is an innovative biologic drug
for the treatment of type 2 diabetes mellitus (T2DM) and NASH.

The results of preclinical animal efficacy experiments showed that B1344 could significantly reduce the degree of hepatic steatosis, balloon-like degeneration and lobule inflammation of the model animals, improve the activity score score and fibrosis of non-alcoholic fatty liver disease, and reduce the serum alanine aminotransferase and aspartate aminotransferase levels, suggesting that B1344 has similar clinical benefit potential
in NASH patients.

The TG103 injection developed by CSPC Pharmaceutical Group is an innovative long-acting recombinant human glucagon-like peptide-1 (GLP-1) Fc fusion protein, which is a glucagon-like peptide-1 receptor agonist (GLP-1 RA), with stable and effective pharmacological effects, good safety and long
drug half-life.

The study found that GLP-1 RA has a significant effect on improving hepatic steatosis and inflammation and reversing liver fibrosis, and preclinical studies of TG103 injection have shown significant improvement in NASH-related symptoms and pathological outcomes, so TG103 injection has significant clinical value in the treatment of NASH The industry expects that based on the complex pathogenesis of NASH and the contradictory interaction of single targets in different signaling pathways, future multi-drug, Multi-target joint application will become a hot spot
in R&D.

Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.